Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth
The OdonAssist™ inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and clinical studies to support development, regulatory approval and post market surveillance of the device...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-01-01
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| Series: | Revista Médica Clínica Las Condes |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S0716864023000123 |
| _version_ | 1811163539098828800 |
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| author | Mario Merialdi |
| author_facet | Mario Merialdi |
| author_sort | Mario Merialdi |
| collection | DOAJ |
| description | The OdonAssist™ inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and clinical studies to support development, regulatory approval and post market surveillance of the device. Resumen: El dispositivo inflable OdonAssist™ para parto vaginal asistido es un dispositivo de investigación que se sometió a pruebas clínicas previas a la comercialización. El plan de generación de evidencia clínica incluye estudios preclínicos y clínicos para respaldar el desarrollo, la aprobación regulatoria y la vigilancia posterior a la comercialización del dispositivo. |
| first_indexed | 2024-04-10T15:06:51Z |
| format | Article |
| id | doaj.art-d2d0961198d149e4987252cec9cc66f7 |
| institution | Directory Open Access Journal |
| issn | 0716-8640 |
| language | English |
| last_indexed | 2024-04-10T15:06:51Z |
| publishDate | 2023-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Revista Médica Clínica Las Condes |
| spelling | doaj.art-d2d0961198d149e4987252cec9cc66f72023-02-15T04:26:52ZengElsevierRevista Médica Clínica Las Condes0716-86402023-01-013412225Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birthMario Merialdi0Maternal Newborn Health Innovations, PBC, Parsippany, NJ, USAThe OdonAssist™ inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and clinical studies to support development, regulatory approval and post market surveillance of the device. Resumen: El dispositivo inflable OdonAssist™ para parto vaginal asistido es un dispositivo de investigación que se sometió a pruebas clínicas previas a la comercialización. El plan de generación de evidencia clínica incluye estudios preclínicos y clínicos para respaldar el desarrollo, la aprobación regulatoria y la vigilancia posterior a la comercialización del dispositivo.http://www.sciencedirect.com/science/article/pii/S0716864023000123Parto Vaginal AsistidoSalud MaternaSalud PerinatalSegunda Fase del Parto |
| spellingShingle | Mario Merialdi Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth Revista Médica Clínica Las Condes Parto Vaginal Asistido Salud Materna Salud Perinatal Segunda Fase del Parto |
| title | Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth |
| title_full | Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth |
| title_fullStr | Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth |
| title_full_unstemmed | Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth |
| title_short | Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth |
| title_sort | generating the clinical evidence for an innovation in maternal and newborn health the odonassist™ inflatable device for assisted vaginal birth |
| topic | Parto Vaginal Asistido Salud Materna Salud Perinatal Segunda Fase del Parto |
| url | http://www.sciencedirect.com/science/article/pii/S0716864023000123 |
| work_keys_str_mv | AT mariomerialdi generatingtheclinicalevidenceforaninnovationinmaternalandnewbornhealththeodonassistinflatabledeviceforassistedvaginalbirth |